The use of the word “automated” in paragraph 2 of 2.1 is not understood. Please explain what an “automated EDMS” is and how this differs from an “EDMS” or remove the word “automated”.
The sentence “For those without access to EDMSs, a method to exchange, view, and navigate content offline is needed” is not understood. The use of an EDMS is unrelated to being online or offline. The issue is simply one of being able to exchange, view and navigate content on electronic repositories containing clinical trial master file content, irrespective of whether those repositories are enterprise systems, EDMSs, Microsoft Access databases or whatever.